(86 days)
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No
The summary describes a standard automated coagulation analyzer using mechanical and photo-optical principles for clot detection, with no mention of AI or ML technologies.
No
The device is a laboratory analyzer used for in vitro diagnostic testing of blood coagulation, not for direct therapeutic intervention on a patient.
Yes
The device is a Coagulation Analyzer used to detect fibrin formation and perform various clotting tests (e.g., prothrombin time, activated partial thromboplastin time), which are diagnostic assays for blood coagulation disorders.
No
The device description clearly identifies the Amelung AMAX CS-190 Coagulation Analyzer as an "automated random access multipurpose analyzer" that utilizes mechanical and photo-optical principles for testing, indicating it is a hardware device.
Yes, based on the provided information, the Amelung AMAX CS-190 Coagulation Analyzer is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used for the "detection of fibrin formation" and to "perform clot based tests" and "chromogenic assays." These are all tests performed on biological samples (like blood or plasma) outside of the body to provide information about a person's health status. This is the core definition of an in vitro diagnostic device.
- Device Description: While the description is brief, it describes an "automated random access multipurpose analyzer," which is a typical type of instrument used in clinical laboratories for performing in vitro diagnostic tests.
- Performance Studies: The performance studies described involve comparing the device's results to other established methods for coagulation testing, which is a standard practice for validating the performance of IVD devices.
- Predicate Devices: The mention of predicate devices (TOA Medical Electronics CA-5000 and BBL Fibrometer) further indicates that this device is being compared to other devices used for in vitro diagnostic testing.
The information provided strongly aligns with the characteristics and regulatory requirements of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
The Amelung AMAX CS-190 Coagulation Analyzer is an automated random access multipurpose analyzer. The AMAX CS-190 Coagulation Analyzer can be used for the detection of fibrin formation utilizing either mechanical principles (ball method) or photo-optical principles to perform clot based tests such as prothrombin time(PT), activated partial thromboplastin time (APTT), fibrinogen, factor assays, and other clotting tests. In addition, the AMAX CS-190 Coagulation Analyzer can be used for chromogenic assays such as antithrombin III (AT III).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In comparison studies of clot based assays between the AMAX CS-190 Coagulation Analyzer (photo-optical or mechanical) and the TOA Medical Electronics CA-5000 (mechanical), the following regression statistics were obtained:
| PT (optical) | r = 0.989 | y = 1.113x - 0.9 |
|---|---|---|
| APTT (optical) | r = 0.907 | y = 0.848x + 7.3 |
| Factor IX (optical) | r = 0.954 | y = 0.950x + 0.7 |
| Factor IX (mechanical) | r = 0.882 | y = 0.882x + 2.3 |
| Factor X (optical) | r = 0.980 | y = 1.019x + 0.0 |
| Factor X (mechanical) | r = 0.976 | y = 1.001x - 0.3 |
| Fibrinogen (optical) | r = 0.979 | y = 1.211x + 0.9 |
In comparison studies of mechanical clot based assays between the AMAX CS-190 Coagulation Analyzer and the BBL Fibrometer, the following regression statistics were obtained:
| PT | r = 0.985 | y = 1.067x - 0.3 |
|---|---|---|
| APTT | r = 0.885 | y = 1.427x +0.4 |
In comparison studies of chromogenic assays between the AMAX CS-190 Coagulation Analyzer and the manual spectrophotometric method, the following regression statistics were obtained:
AT III r = 0.848 y = 0.848x + 5.0x
The coefficient of variation for precision studies was less than 4% for the PT and APTT assays, less than 9% for the factor assays, less than 10% for the fibrinogen assays, and less than 6% for AT III.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
0
Sigma Diagnostics 545 South Ewing Avenue St. Louis, MO 63103
AMAX CS-190 Coagulation Analyzer December 15, 1995
K9557XO
MAR 1 3 1996
ATTACHMENT 1
Summary of Safety and Effectiveness
1
AMAX CS-190 Coagulation Analyzer December 15, 1995
ATTACHMENT 1
510(k) Summary of Safety and Effectiveness
The Amelung AMAX CS-190 Coagulation Analyzer is an automated random access multipurpose analyzer. The AMAX CS-190 Coagulation Analyzer can be used for the detection of fibrin formation utilizing either mechanical principles (ball method) or photo-optical principles to perform clot based tests such as prothrombin time(PT), activated partial thromboplastin time (APTT), fibrinogen, factor assays, and other clotting tests. In addition, the AMAX CS-190 Coagulation Analyzer can be used for chromogenic assays such as antithrombin III (AT III).
In comparison studies of clot based assays between the AMAX CS-190 Coagulation Analyzer (photo-optical or mechanical) and the TOA Medical Electronics CA-5000 (mechanical), the following regression statistics were obtained:
| PT (optical) | r = 0.989 | y = 1.113x - 0.9 |
|---|---|---|
| APTT (optical) | r = 0.907 | y = 0.848x + 7.3 |
| Factor IX (optical) | r = 0.954 | y = 0.950x + 0.7 |
| Factor IX (mechanical) | r = 0.882 | y = 0.882x + 2.3 |
| Factor X (optical) | r = 0.980 | y = 1.019x + 0.0 |
| Factor X (mechanical) | r = 0.976 | y = 1.001x - 0.3 |
| Fibrinogen (optical) | r = 0.979 | y = 1.211x + 0.9 |
In comparison studies of mechanical clot based assays between the AMAX CS-190 Coagulation Analyzer and the BBL Fibrometer, the following regression statistics were obtained:
| PT | r = 0.985 | y = 1.067x - 0.3 |
|---|---|---|
| APTT | r = 0.885 | y = 1.427x +0.4 |
In comparison studies of chromogenic assays between the AMAX CS-190 Coagulation Analyzer and the manual spectrophotometric method, the following regression statistics were obtained:
$$\textbf{AT} \amalg \textbf{I} \tag{14.11} \qquad \qquad \qquad \textbf{r} = \textbf{0.848} \qquad \qquad \qquad \qquad \textbf{y} = \textbf{0.848x} + \textbf{5.0x} \qquad \qquad \qquad \qquad \qquad \textbf{F} = \textbf{0.1272x} \qquad \qquad \qquad \textbf{F} = \textbf{0.1272y} \qquad \qquad \qquad \textbf{F} = \textbf{0.1272y} \qquad \qquad \qquad \textbf{F} = \textbf{0.1272y} \qquad \qquad \qquad \textbf{F} = \textbf{0.1272y} \qquad \qquad \qquad \textbf{F} = \textbf{0.1272y} \qquad \qquad \textbf{F} = \textbf{0.1272y} \qquad \qquad \textbf{F} = \textbf{0.1272y} \qquad \qquad \textbf{F} = \textbf{0.1272y} \qquad \qquad \textbf{F} = \textbf{0.1272y} \qquad \qquad \textbf{F} = \textbf{0.1272y} \qquad \textbf{F} = \textbf{0.1272y} \qquad \textbf{F} = \textbf{0.1272y} \qquad \textbf{F} = \textbf{0.1272y} \qquad \textbf{F} = \textbf{0.1272y} \qquad \textbf{F} = \textbf{0.1272y} \qquad \textbf{F} = \textbf{0.1272y} \qquad \textbf{F} = \textbf{0.1272y} \qquad \textbf{F} = \textbf{0.1272y} \qquad \textbf{F} = \textbf{0.1272y} \qquad \textbf{F} = \textbf{0.1272y} \qquad \textbf{F} = \textbf{0.1272y} \qquad \textbf{F} = \textbf{0.1272y} \qquad \textbf{F} = \textbf{0.1272y} \qquad \textbf{F} = \textbf{0.1272y} \qquad \textbf{F} = \textbf{0.1272y$$
The coefficient of variation for precision studies was less than 4% for the PT and APTT assays, less than 9% for the factor assays, less than 10% for the fibrinogen assays, and less than 6% for AT III.
The safety and effectiveness of the AMAX CS-190 Coagulation Analyzer is demonstrated by its substantial equivalency to the predicate devices.